Cocaine Opioid Oxytocin Option - Limited

Opioid Use Disorder Clinical Trial

— COOOL  

Official title:

Chronic Intranasal Oxytocin as an Adjunct to Methadone Maintenance Treatment in Patients With Co-occuring Opioid Use Disorder and Cocaine Use: A 2-week Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028533
• Other study ID #: 13-12534
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program

• Stable dose of methadone for at least the past two weeks

• At least one routine urine toxicology screen positive for cocaine in the past month

Exclusion Criteria:

• Positive urine pregnancy test

• Use of illicit drugs in the past month (with the exception of cocaine or cannabis)

• Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions

• History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria

• Severe neuropsychological disorder, brain trauma, epilepsy

• Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)

• Nasal obstruction, discharge, or bleeding

• Habitually drinks large volumes of water

• Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Disease
• Opioid Use Disorder
• Substance-Related Disorders

Intervention

Drug:
• Oxytocin

• Placebo

Locations

Country	Name	City	State
United States	San Francisco General Hospital Opiate Treatment Outpatient Program	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with non-serious and serious adverse events		3 weeks